TECNIS IOL ZXT150 (REF ZXT150U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05050474605237), received between Jan 31, 2017 and Mar 18, 2023 — classified as 22 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE. NO MEDICAL OR OTHER SURGICAL INTERVENTIONS WERE INDICATED. IT WAS INDICATED THE PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 16569810 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AT THE 3-MONTH STUDY VISIT ZXT150 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. OS MONOCULAR BCDVA AT 3-MONTH VISIT WAS 20/16 AND PREOP BCDVA WAS 20/25. IT WAS REPORTED THE PATIENT IS EXTREMELY BOTHERED BY HALOS, STARBURSTS, AND GLARE, CAUSING DIFFICULTY DRIVING AT NIGHT. THE PATIENT WILL RECEIVE A LIPIFLOW TREATMENT PER THE STUDY PROTOCOL, WILL RETURN IN 4-6 WEEKS FOR A FOLLOW-UP VISIT, AND NO OTHER TREATMENT IS PLANNED AT THIS TIME. AT THE FOUR (04) MONTH STUDY VISIT, SUBJECT REPORTED EXTREME HALOS AND STARBURSTS, MODERATE BOTHER WITH GLARE, ALL OF WHICH CAUSED DIFFICULTY WITH DRIVING, AND MODERATE BOTHER WITH MULTIPLE OR DOUBLE VISION, CAUSING THEM TO BLINK A LOT WHILE READING. THE MONOCULAR BCDVA FOR THIS VISIT WAS 20/25 OS. NO FURTHER INTERVENTION WAS SCHEDULED AT THE TIME OF THE VISIT. THIS WAS THE FINAL STUDY VISIT FOR THIS SUBJECT, SO WE WILL NOT RECEIVE ANY MORE UPDATES UNLESS AN INTERVENTION TAKES PLACE. THE PATIENT HAS BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE IOL IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). A SEPARATE REPORT WILL BE FILED FOR THE PATIENT'S OCULAR DEXTER - R

  Patient problems: Halo; No Code Available

  MAUDE report 9289574 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AT THE 3-MONTH STUDY VISIT ZXT150 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. OD MONOCULAR BEST CORRECTED DISTANT VISUAL ACUITY (BCDVA) AT 3-MONTH VISIT WAS REPORTED AS 20/16 AND PREOP BCDVA WAS 20/25. IT WAS REPORTED THE PATIENT IS EXTREMELY BOTHERED BY HALOS, STARBURSTS, AND GLARE, CAUSING DIFFICULTY DRIVING AT NIGHT. THE PATIENT WILL RECEIVE A LIPIFLOW TREATMENT PER THE STUDY PROTOCOL, WILL RETURN IN 4-6 WEEKS FOR A FOLLOW-UP VISIT, AND NO OTHER TREATMENT IS PLANNED AT THIS TIME. AT THE FOUR (04) MONTH STUDY VISIT, SUBJECT REPORTED EXTREME HALOS AND STARBURSTS, MODERATE BOTHER WITH GLARE, ALL OF WHICH CAUSED DIFFICULTY WITH DRIVING, AND MODERATE BOTHER WITH MULTIPLE OR DOUBLE VISION, CAUSING THEM TO BLINK A LOT WHILE READING. THE MONOCULAR BCDVA FOR THIS VISIT WAS 20/16 OD. NO FURTHER INTERVENTION WAS SCHEDULED AT THE TIME OF THE VISIT. THIS WAS THE FINAL STUDY VISIT FOR THIS SUBJECT, SO WE WILL NOT RECEIVE ANY MORE UPDATES UNLESS AN INTERVENTION TAKES PLACE. THE PATIENT HAS BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE IOL IMPLANTED IN THE PATIENT'S OCULAR DEXTER - RIGHT EYE. A SEPARATE REPORT

  Patient problems: Halo; No Code Available

  MAUDE report 9289561 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), MODEL ZXT150 21.5 DIOPTER WAS EXPLANTED FROM PATIENT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE THE PATIENT HAS A PTERIGYIUM AND IT CONTRIBUTED TO THE LENS BEING THE WRONG CALCULATION. THE PATIENT COMPLAINS OF TROUBLE WITH QUALITY OF VISION. IT WAS INDICATED THAT THE PATIENT'S OUTCOME WAS GOOD AT THE TIME OF DISCHARGE. THE DEVICE IS AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9255488 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CONTACTED JOHNSON & JOHNSON SURGICAL VISION TO REPORT HER EXPERIENCE WITH THE INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED IN HER RIGHT EYE. REPORTEDLY, THE LENS WAS IMPLANTED IN (B)(6) AND SHE EXPERIENCED DIFFICULTIES, TO INCLUDE NOT BEING ABLE TO SEE AFTER SURGERY OR AFTER SUBSEQUENT FOLLOW-UP VISITS, SO HER DOCTOR EVALUATED HER EYES AND THEY TOLD HER SHE HAD HAD THE WRONG DIOPTER IMPLANTED. THIS WAS UNABLE TO BE CORRECTED WITH GLASSES. HE OFFERED TO REPLACE LENS FOR FREE, BUT SHE HAD LOST CONFIDENCE IN HIS ABILITY. POST OP SYMFONY IMPLANT, VISUAL ACUITY WAS 20/50 DISTANCE IN HER RIGHT EYE. HAD BLURRY VISION ALONG WITH HALOS/GLARE FOR 2 MONTHS. THE PATIENT RETURNED TO NEW YORK AND FOUND ANOTHER DOCTOR, A SPECIALIST WHO EXPLANTED THE LENS. THE LENS WAS REPLACED WITH A MODEL ZLB00, 21.5 DIOPTER (B)(6) 2019. PATIENT ALSO MENTIONED, SHE HAD A SCRATCHED RETINA DURING THE SURGERY AND ALSO LOST HER LOWER LASHES. SHE WAS TREATED WITH DROPS. POST OP SHE SEES VERY WELL NOW. SHE IS ABLE TO WORK AS AN ATTORNEY AND VERY HAPPY SHE CAN NOW READ DOCUMENTS, THE COMPUTER AND SUCH. SHE DID NOT COMPLAIN ABOUT HER DISTANCE VISION. PATIENT STATED SHE COULD SEE GREAT OUT OF THIS EYE; HOWEVER,

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 8988075 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS INCLUDED IN A CLINICAL STUDY OF LENSES. THE PATIENT WAS IMPLANTED A BILATERAL ZXT150 INTRAOCULAR LENS (IOL). IT WAS LEARNT THAT AT ABOUT THE 6TH MONTH OF FOLLOW-UP, THE SUBJECT NOTED: VERY BOTHERED BY HALOS: DIFFICULT TO SEE CLEARLY WHEN HEADLIGHTS ARE FACING TOWARD ME/ALSO HAVE HALOS IN MY HOME AROUND LIGHT SOURCES LIKE CLOCK RADIO LIGHT. VERY BOTHERED BY STARBURSTS: SEEING CLEARLY WHEN HEADLIGHTS ARE COMING AT ME AT NIGHT. VERY BOTHERED BY GLARE RELATED TO SCATTERED LIGHT: VERY BOTHERED ON A TWO LANE ROAD. MODERATELY BOTHERED BY POOR LOW LIGHT VISION: READING MENUS OR SMALL PRINT THE SYMPTOMS DO INTERFERE WITH DAILY ACTIVITIES. THE IOLS STILL REMAIN IMPLANTED IN THE SUBJECT IN BOTH EYES WITH NO INTERVENTION PLANNED. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA): RIGHT EYE (OD) 20/40 LEFT EYE (OS) 20/50 6 MONTH BCVA OD 20/20 OS 20/20. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8975304 ↗
• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE 3-MONTH STUDY VISIT, THE PATIENT REPORTED BEING MODERATELY BOTHERED BY POOR LOW LIGHT VISION WHEN READING. VISUAL ACUITY: J1 RIGHT EYE (OD); J1 LEFT EYE (OS). ADDITIONAL INFORMATION RECEIVED REPORTED THE UNCORRECTED BILATERAL NEAR VISION WAS 20/25 AT THE 3-MONTH VISIT. BEST CORRECTED MONOCULAR VISION WAS 20/16 OD AND 20/12.5 OS. AT THE 1-MONTH STUDY VISIT, THE PATIENT REPORTED MODERATELY BOTHERED WITH VISUAL SYMPTOMS (POOR LOW LIGHT VISION WITH SIGNIFICANT DIFFICULTY READING AT NEAR AND GLARE). THE SYMPTOMS SIGNIFICANTLY INTERFERES WITH DAILY ACTIVITIES. THERE ARE NO PLANS FOR MEDICAL OR SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS RECEIVED. THIS REPORT IS FOR THE RIGHT EYE. A SEPARATE MDR HAS BEEN SUBMITTED FOR THE LEFT EYE.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8681080 ↗
• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE 3-MONTH STUDY VISIT, THE PATIENT REPORTED BEING MODERATELY BOTHERED BY POOR LOW LIGHT VISION WHEN READING. VISUAL ACUITY: J1 RIGHT EYE (OD); J1 LEFT EYE (OS). ADDITIONAL INFORMATION RECEIVED REPORTED THE UNCORRECTED BILATERAL NEAR VISION WAS 20/25 AT THE 3-MONTH VISIT. BEST CORRECTED MONOCULAR VISION WAS 20/16 OD AND 20/12.5 OS. AT THE 1-MONTH STUDY VISIT, THE PATIENT REPORTED MODERATELY BOTHERED WITH VISUAL SYMPTOMS (POOR LOW LIGHT VISION WITH SIGNIFICANT DIFFICULTY READING AT NEAR AND GLARE). THE SYMPTOMS SIGNIFICANTLY INTERFERES WITH DAILY ACTIVITIES. THERE ARE NO PLANS FOR MEDICAL OR SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS RECEIVED. THIS REPORT IS FOR THE LEFT EYE. A SEPARATE MDR HAS BEEN SUBMITTED FOR THE RIGHT EYE.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8681076 ↗
• MalfunctionJun 3, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AT THE PATIENT'S 1-MONTH'S'S VISIT THE INTRAOCULAR LENS (IOL) LENS HAD ROTATED. REPORTEDLY, THE LENS WAS ORIGINALLY PLACED AT 38 DEGREES AND IS NOW AT 55 DEGREES. THE PATIENT HAS 20/20 VISION. THERE WAS NO PATIENT COMPLICATION OR INJURY AND THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THERE IS NO SURGERY PLANNED FOR THIS IOL MISALIGNMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8664278 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150, 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED BUT POST IMPLANT THE PATIENT EXPERIENCED REFRACTIVE ERROR AND GLARE. THE IOL WAS EXPLANTED AND EXCHANGED WITH NO PATIENT INJURY, NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURE. OUTCOME WAS GOOD. REPLACEMENT LENS WAS A ZCT150 21.0 DIOPTER IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8163303 ↗
• InjuryOct 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) MODEL ZXT150 +21.5 DIOPTER WAS IMPLANTED INTO THE PATIENT''S RIGHT EYE (OD) ON (B)(6) 2018. REPORTEDLY, THE PATIENT COMPLAINED OF GLARE, ''WHITE VISION'' AND POOR VISION QUALITY. THE LENS WAS EXPLANTED ON (B)(6) 2018 AND THERE WERE NO COMPLICATIONS DURING THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Visual Impairment

  MAUDE report 7959676 ↗
• InjurySep 27, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A ZXR00 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO MECHANICAL FAILURE. THERE WAS AN INCISION ENLARGEMENT, BUT NO INJURY TO THE PATIENT. REPORTEDLY, THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7916985 ↗
• InjuryJul 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISABLING GLARE & HALOS AROUND LIGHTS WITH NIGHT DRIVING AND LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. PER FOLLOW-UP, SYMPTOMS STARTED NINE (9) DAYS POST OP. THE PATIENT'S AFFECTED EYE WAS ON THE RIGHT EYE (OD). AN INCISION ENLARGEMENT WAS REQUIRED AT EXPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7666397 ↗
• InjuryJul 3, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REPORTEDLY, THE PATIENT HAS COMPLAINED SINCE HER FIRST POST-OP DAY THAT SHE HAS A BLURRED HAZE AROUND ALL OBJECTS WHICH IS INTENSIFIED BY LIGHT. THE DATE OF IMPLANT WAS (B)(6) 2018. THE PATIENT¿S VISION WAS 20/15 AT DISTANCE AND J1 AT NEAR. THE DOCTOR REPORTED THAT THE SYMFONY INTRAOCULAR LENS (IOL) IS CENTERED PERFECTLY, BUT APPEARS TO HAVE CIRCULAR SWIRL MARKS ON THE ANTERIOR SURFACE OF THE CENTRAL OPTIC, WHICH SEEM TO BE PERFECTLY SYMMETRICAL AND COULD NOT HAVE BEEN DONE BY HUMAN HANDS. PER FOLLOW-UP, THE LENS WAS EXPLANTED (B)(6) 2018 AND REPLACED WITH THE SAME MODEL, A SMALLER DIOPTER SIZE LENS. PATIENT WAS DOING FINE POST-SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 7661563 ↗
• InjuryApr 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 21.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. HOWEVER, THE LENS IS PLANNED TO BE EXPLANTED ON (B)(6) 2018 FOR UNKNOWN REASONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7449651 ↗
• MalfunctionMar 21, 2018Crack; Crack

  IT WAS REPORTED THAT TWO CRACKS WERE NOTICED ON AN INTRAOCULAR LENS (IOL) UPON RECEIPT. NO PATIENT CONTACT WAS REPORTED. A DIFFERENT LENS WAS USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7356509 ↗
• InjuryFeb 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED SOMETIME IN (B)(6) 2018 DUE TO UNKNOWN REASONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7264428 ↗
• InjuryJan 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150, +21.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE. MODEL ZCT150, DIOPTER +21.5 INTRAOCULAR LENS WAS IMPLANTED AS REPLACEMENT LENS FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7201942 ↗
• InjuryDec 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC LENS (MODEL # ZXT150 21.5 DIOPTER) WAS IMPLANTED ON (B)(6) 2017, AND IS SCHEDULED TO BE EXPLANTED ON (B)(6) 2017 DUE TO SEVERE STARBURST ON A (B)(6) FEMALE PATIENT WITH PRIOR HISTORY OF ASTIGMATISM. REPORTEDLY, THE PATIENT WAS DOING WELL AFTER THE FIRST SURGERY. PER FOLLOW UP FROM THE DOCTOR, THE LENS WAS EXPLANTED ON (B)(6) 2017, AS PLANNED AND REPLACED WITH A NON-AMO LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7077558 ↗
• InjuryOct 9, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT150 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE IT WAS NOT ABLE TO CENTER PROPERLY AFTER A MONTH OF IMPLANTATION. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE PATIENT IS FINE AND NO POST-OPERATIVE PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6933081 ↗
• InjuryAug 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL ZXT150 21.5 DIOPTERS, WAS IMPLANTED ON (B)(6) 2016. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT WAS COMPLAINING OF HALOS AND GLARE. THE REPLACEMENT WAS A Z9002 22.5 DIOPTER LENS, WHICH WAS SUCCESSFULLY IMPLANTED IN IT'S PLACE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6804460 ↗
• MalfunctionAug 3, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT A SCRATCH WAS NOTICED ON AN INTRAOCULAR LENS (IOL) UPON OPENING THE LENS CASE. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6762693 ↗
• InjuryMar 7, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT150 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO PATIENT EXPERIENCING EXCESSIVE GLARE, HALOS DECREASED ACUITY AND BLURRY VISION. FURTHERMORE, THE PHYSICIAN NOTED THAT THERE WAS LENS DISLOCATION. THE LENS WAS REPLACED WITH A ZMA00 20.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT AND PATIENT HAS RECOVERED. ADDITIONALLY, IT WAS REPORTED THAT THE LENS WAS DISCARDED AND NOT AVAILABLE FOR EVALUATION.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 6386027 ↗
• InjuryFeb 28, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A FEMALE PATIENT. REPORTEDLY, THE LENS ROTATED 90 DEGREES REQUIRING LENS REPOSITIONING ONE WEEK AFTER IMPLANTATION. NO PATIENT INJURY WAS REPORTED. VA (VISUAL ACUITY) BEFORE ROTATION: 1 DAY POST OP: 20/60 J1+, 5 DAYS POST OP 20/60 J1 VA AFTER ROTATION: 1 DAY POST OP 20/30 J2 ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PATIENT WAS SEEN AGAIN BY THE SURGEON ON (B)(6) 2017. THE PATIENT WAS REPORTED DOING WELL (20/30 J1). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6363444 ↗
• InjuryJan 31, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT ZXT150 21.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE DUE TO THE WRONG LENS POWER BEING IMPLANTED WHICH RESULTED IN THE PATIENT BEING OVER MINUS. THE LENS WAS REPLACED WITH ANOTHER ZXT150 LENS OF A LOWER DIOPTER (20.0). THERE WAS NO VITRECTOMY, NO INCISION ENLARGEMENT OR SUTURE REQUIRED. PATIENT IS DOING FINE.

  Patient problems: No Code Available

  MAUDE report 6291453 ↗